Market Newsdesk

PRINCETON, N.J., Sept. 29, 2022 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, today issued its inaugural Environmental, Social and Governance (ESG) report. The report includes 2021 performance highlights in key areas such as employee health and safety, diversity and inclusion, community impact, ethics and compliance, and environmental responsibility. The report also includes the company’s ESG strategy and roadmap to long-term sustainability.

“Our company purpose and values have long guided our global sustainability priorities, and we have a deeply entrenched ESG mindset and culture. Building sustainable organizations not only makes business sense, but it also is the right thing to do,” said Jan De Witte, president and chief executive officer, Integra LifeSciences. “Every day, Integra colleagues deliver lifesaving and life-enhancing products and technologies to our customers and fulfill our responsibility to preserve the health of patients and the planet.”

Highlights of the report include:

• Identification and ranking of our top 12 ESG priorities based on feedback from internal and external stakeholders;
• Expansion of board oversight to formally include ESG strategy, stakeholder engagement and reporting;
• An update on our diversity and inclusion efforts, which include an increase in the number of employee resource groups and the advancement of women in leadership positions;
• A description of our environmental, health, safety, and security policies and governance structure, including the digitization of our EHS management systems; and
• The calculation of our direct greenhouse gas emissions and a commitment to setting concrete reduction targets in the near future.

Integra prepared this ESG report in alignment with several external guidelines and measurement frameworks, including the Global Reporting Index and the Sustainability Accounting Standards Board Index.

Read the full Integra ESG Report here.

About Integra LifeSciences

Integra LifeSciences is a global leader in regenerative tissue technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel^®, Aurora^®, Bactiseal^®, BioD™, CerebroFlo^®, CereLink^® Certas^® Plus, Codman^®, CUSA^®, Cytal^®, DuraGen^®, DuraSeal^®, Gentrix^®, ICP Express^®, Integra^®, Licox^® , MAYFIELD^®, MediHoney^®, MicroFrance^®, MicroMatrix^®, NeuraGen^®, NeuraWrap^™, PriMatrix^®, SurgiMend^®, TCC-EZ^® and VersaTru^®. For the latest news and information about Integra and its products, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the economic, competitive, governmental, technological, and other factors identified under the heading “Risk Factors” included in item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2021, and information contained in subsequent filings with the Securities and Exchange Commission. These forward-looking statements are made only as the date thereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors:


Chris Ward
(609) 936-2322
[email protected]

Media:


Laurene Isip
(609) 208-8121
[email protected]

LOS ANGELES, Sept. 29, 2022 (GLOBE NEWSWIRE) — via InvestorWire – Freight Technologies Inc. (NASDAQ: FRGT), a technology company that develops solutions to optimize and automate the supply chain process, today announces it has selected the corporate communications expertise of IBN, a multifaceted financial news and publishing company for private and public entities.

Freight Technologies provides a platform (Fr8App) for B2B cross-border shipping and domestic shipping within the United States-Mexico-Canada (NAFTA) region. The company’s mission is to revolutionize cross-border shipping by providing carriers with increased growth opportunities and shippers with flexibility, visibility and simplicity for the once-complex process of international over-the-road shipping. Freight Technologies leverages artificial intelligence to provide cloud-based platforms aimed at automating the over-the-road transportation process, effectively reducing human touch points and expediting load booking times.

The company’s suite of solutions includes:

• 
  
  Fr8app
  
  – A B2B marketplace powered by AI and machine learning offering a real-time broker portal to connect shippers with qualified carriers
• Fr8Radar – A tracking solution providing shippers and carriers real-time locational data via Fr8app’s mobile solution or through integration with third-party GPS alternatives
• Fr8TMS – A transportation management system designed to help shippers manage their freight and all of the documents involved in shipping transactions, including invoices, customs documents, confirmation rates and proof of deliveries
• Fr8FMS – A fleet management system allowing transportation companies to better manage their fleets, reduce operational costs and provide better service to their customers
• Fr8Data – A data solution offering real-time dashboards and reports to shippers and carriers in an effort to increase visibility and control while supporting better business decisions
• Fr8Fleet – A platform that provides private fleet management, enabling large corporate shippers to purchase dedicated capacity secured by Fr8app in exchange for a fixed fee

As part of the Client Partner relationship, IBN will leverage its investor based distribution network of 5,000+ key syndication outlets, various newsletters, social media channels, wire services via InvestorWire, blogs and other outreach tools to generate greater awareness for Freight Technologies.

With 15+ years of experience assisting 500+ client partners improve communications within the investment community, and a sizable family of 50+ trusted brands, IBN has amassed a collective audience that includes millions of social media followers. IBN is uniquely positioned to provide Freight Technologies the solutions needed to reach a wide audience of investors, consumers, journalists and the general public.

“Thousands of legacy brokers, tens of thousands of shippers and hundreds of thousands of carriers still rely on outdated systems to arrange transport. Through Fr8app, Freight Technologies is leveraging AI and machine learning to connect shippers with qualified carriers in real time,” states Chris Johnson, Director of Client Solutions for IBN. “We’re excited to customize our comprehensive suite of corporate communications solutions for Freight Technologies as it works to improve the efficiency and sustainability of cross-border shipping across North America.”

To learn more about Freight Technologies, please visit the company’s corporate newsroom @ www.IBN.fm/FRGT

About Freight Technologies Inc.

Freight Technologies is a technology company developing solutions to optimize and automate the supply chain process. Its wholly owned subsidiary, Freight App Inc. (Fr8app), is a B2B cross-border shipping marketplace in the NAFTA region powered by AI and machine learning. Focused on making shipping transparent and efficient, Fr8app provides carriers with increased growth opportunities and shippers with flexibility, visibility and simplicity for the once-complex process of international over-the-road (OTR) shipping. Fr8app uses its proprietary technology platform to connect carriers and shippers and significantly improve matching and operation efficiency via innovative technologies such as live pricing and real-time tracking, digital freight marketplace, broker, transportation management, fleet management and committed capacity solutions. The company is headquartered in Houston, Texas. For more information, visit the company’s website at www.Fr8Technologies.com

About IBN

IBN
consists of financial brands introduced to the investment public over the course of 15+ years. With IBN, we have amassed a collective audience of millions of social media followers. These distinctive investor brands aim to fulfill the unique needs of a growing base of client-partners. IBN will continue to expand our branded network of highly influential properties, leveraging the knowledge and energy of specialized teams of experts to serve our increasingly diversified list of clients.

Through NetworkNewsWire (“NNW”) and its Investor Brand Platform, IBN provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) Press Release Enhancement to ensure maximum impact; (4) full-scale distribution to a growing social media audience; (5) a full array of corporate communications solutions; and (6) total news coverage solutions.

For more information, please visit https://www.InvestorBrandNetwork.com

Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://IBN.fm/Disclaimer

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Fr8Tech Contact:

[email protected]

Corporate Communications

IBN (InvestorBrandNetwork)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
[email protected]

CAMBRIDGE, Mass., Sept. 29, 2022 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy. SRP-9001 is an investigational gene therapy for Duchenne being developed in partnership with Roche.

The BLA is submitted for accelerated approval based on the expression of SRP-9001 dystrophin protein, an internally shortened and functional version of dystrophin, as a surrogate endpoint reasonably likely to predict clinical benefit. Among other things, the BLA is based on positive pre-clinical, biomarker and clinical functional results. In clinical trials, SRP-9001 demonstrated positive results at multiple time points, including one-, two- and four-years after treatment, in addition to a consistent safety profile. The submitted BLA for SRP-9001 includes efficacy and safety data from Studies SRP-9001-101, SRP-9001-102, SRP-9001-103 (also known as ENDEAVOR), as well as an integrated analysis across these three clinical studies comparing functional results to a propensity-score-matched external control (EC). Quantification of the SRP-9001-protein expression is measured by western blot and supported by immunofluorescence and efficacy is further supported by biomarker and clinical functional benefit as measured by the North Star Ambulatory Assessment (NSAA) and secondary timed tests.

Sarepta has proposed its fully-enrolled study EMBARK (Study SRP-9001-301) as the post-marketing confirmatory study to support the accelerated approval. EMBARK is a global, randomized, double-blind, placebo-controlled clinical trial. The primary endpoint for EMBARK is the assessment of the change in NSAA total score from baseline to week 52 compared to placebo.

“Every hour of every day, this ruthless disease, Duchenne, robs thousands of children in the United States of muscle as it steals their future from them. Sarepta’s BLA submission for an accelerated approval of SRP-9001 is a significant milestone in our quest to intervene with urgency on behalf of the children we serve,” said Doug Ingram, president and chief executive officer, Sarepta Therapeutics. “If approved, SRP-9001 will be the first gene therapy available for Duchenne patients. We are enormously grateful to the courageous families who have participated in the SRP-9001 trials and to the participating clinical investigators and experts who have guided us and played a crucial part in reaching this milestone.”

SRP-9001 was granted Fast Track designation in July 2020, an FDA process designed to facilitate the development and expedited review of therapies that treat serious conditions and fill unmet medical needs. In addition to Fast Track, SRP-9001 has also been granted Rare Pediatric Disease (RPD) designation in the United States, and Orphan Drug status in the United States, the European Union, Switzerland and Japan.

About SRP-9001 (delandistrogene moxeparvovec)


SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP-9001 to muscle tissue for the targeted production of functional components of dystrophin. Sarepta is responsible for global development and manufacturing for SRP-9001 and plans to commercialize SRP-9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for Duchenne to accelerate access to SRP-9001 for patients outside the United States.

About Duchenne Muscular Dystrophy


Duchenne muscular dystrophy (DMD) is a rare, fatal neuromuscular genetic disease that occurs in approximately one in every 3,500-5,000 newborn males worldwide. DMD is caused by a change or mutation in the gene that encodes instructions for dystrophin. Symptoms of DMD usually appear in infants and toddlers. Affected children may experience developmental delays such as difficulty in walking, climbing stairs or standing from a sitting position. As the disease progresses, muscle weakness in the lower limbs spreads to the arms and other areas. Most patients require full-time use of a wheelchair in their early teens, and then progressively lose the ability to independently perform activities of daily living such as using the restroom, bathing and feeding. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and patients usually succumb to the disease in their twenties.

About Sarepta Therapeutics


Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of Information


We routinely post information that may be important to investors in the ‘For Investors’ section of our website at 


www.sarepta.com


. We encourage investors and potential investors to consult our website regularly for important information about us.

Forward-Looking Statements


This press release contains “forward-looking statements.” Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the benefits of SRP-9001; the potential for SRP-9001 to be the first approved gene therapy for Duchenne
available to the majority of those with Duchenne;
our expectation to use our
fully-enrolled study EMBARK (Study SRP-9001-301) as the post-
marketing
confirmatory study to support the accelerated approval
and our quest to intervene with urgency on behalf of the children we serve.

These forward-looking statements involve risks and uncertainties, many of which are beyond our control. Known risk factors include, among others: the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business, as well as the development of our product candidates and our financial and contractual obligations; that we may not be able to execute on our business plans and goals, including meeting our expected or planned regulatory milestones and timelines, clinical development plans, and bringing our product candidates to market, due to a variety of reasons, some of which may be outside of our control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates, and the COVID-19 pandemic; success in pre-clinical trials and early clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials of our product candidates are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2021, and most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

Source: Sarepta Therapeutics, Inc.

Investor Contact:


Ian Estepan, 617-274-4052
[email protected]

Media Contact:


Tracy Sorrentino, 617-301-8566
[email protected]

EL SEGUNDO, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) — As US auto sales are forecasted to be majority EV by 2030, Navitas Semiconductor (Nasdaq: NVTS), the only pure-play, next-generation power semiconductor company, will showcase industry-leading gallium nitride (GaN) and silicon carbide (SiC) technologies at the IEEE Energy Conversion Congress & Expo (ECCE) in Detroit, Michigan (October 9^th-13^th).ⁱ

ECCE 2022 features both industry-driven and application-oriented technical sessions, as well as industry expositions and seminars in electrical and electromechanical energy conversion. It provides engineers, researchers, and professionals a perfect blend of state-of-the-art, technical prowess and commercial opportunities.

Navitas’ 650 V-rated GaNFast power ICs with GaNSense™ technology are optimized for the broad range of 400 V-rated EV battery applications and AC-interfacing. New Navitas GeneSiC 1200 V FETs and diodes address 800 V-rail applications for higher-power trucks, buses, and performance passenger cars. Navitas’ unique EV System Design Center provides complete platform designs to accelerate time-to-market, including a 3-in-1 800 V-rated bi-directional charger and DC-DC converter, with up to 18% weight savings, up to 20% energy savings, and up to 65% faster charging than competing solutions.

“Upgrading from legacy silicon to GaN and SiC accelerates EV adoption by two years,” said Llew Vaughan-Edmunds, senior director of marketing at Navitas Semiconductor. “ECCE is a critical forum for professionals working to optimize power conversion across the EV landscape, and a fertile environment for detailed discussions on new technology adoption.”

ECCE 2022 is at Huntington Place, 1 Washington Blvd., Detroit, MI 48226. Navitas will feature in a focus session on SiC and GaN applications in EV from 12.30 pm to 2.10 pm (EDT) on Monday 10^th October.

To meet with Navitas at ECCE, please contact [email protected].

About Navitas

Navitas Semiconductor (Nasdaq: NVTS), founded in 2014, is the only pure-play, next-generation power-semiconductor company (and industry leader in GaN power ICs and SiC technology). GaNFast™ power ICs integrate gallium nitride (GaN) power and drive, with control, sensing, and protection to enable faster charging, higher power density, and greater energy savings. Complementary GeneSiC™ power devices are optimized high-power, high-voltage, and high-reliability silicon carbide (SiC) solutions. Focus markets include mobile, consumer, data center, EV, solar, wind, smart grid, and industrial. Over 185 Navitas patents are issued or pending. Over 50 million GaN units have been shipped to customers including Samsung, Dell, Lenovo, and Xiaomi, with zero reported GaN field failures. Navitas introduced the industry’s first and only 20-year warranty. Navitas is the world’s first semiconductor company to be CarbonNeutral^®-certified.

Navitas Semiconductor, GaNFast, GaNSense, GeneSiC, and the Navitas logo are trademarks or registered trademarks of Navitas Semiconductor Limited. All other brands, product names, and marks are or may be trademarks or registered trademarks used to identify products or services of their respective owners.

Contact Information:

Stephen Oliver, VP Corporate Marketing & Investor Relations, [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f5e481b2-5939-41cb-a3d0-ad041d8ce900

HERZLIYA, Israel, Sept. 29, 2022 (GLOBE NEWSWIRE) — Safe-T Group Ltd. (NASDAQ: SFET) (TASE: SFET) (“Safe-T” or the “Company”), a global provider of cybersecurity and privacy solutions to consumers and enterprises, today announced that its Apple iOS privacy application is ranking among the top ten privacy applications (category: productivity) in the U.S. App Store.

App Store ranks are determined by keyword and metadata optimization. Additional factors include user reviews, application performance, click-through rate (CTR), marketing, productivity and more.

Safe-T’s Consumer Privacy solution provides users with a robust privacy protection tool. Utilizing advanced encryption technologies, the privacy solution prevents access to and monitoring of a user’s personal data. By blocking the ability to track or monitor a user’s online and historical activity, their personal information remains private. The application is currently available for Android, Apple iOS, and Windows personal computer users.

“We are pleased with the traction our privacy application is gaining from iOS users and are extremely proud to have our first application ranked high among the strongest brands in this space within such a short time following its launch,” commented Shachar Daniel, Chief Executive Officer of Safe-T. “We intend to continue to invest in our technology to provide the best solutions to our current and future customers and increase our high-margin growth in recurring revenue.”

About Safe-T® Group Ltd.

Safe-T Group Ltd. (Nasdaq, TASE: SFET) is a global provider of cyber-security and privacy solutions to consumers and enterprises. The Company operates in three distinct segments, tailoring solutions according to specific needs. The segments include, enterprise cyber-security solutions, enterprise privacy solutions, and consumer cyber-security and privacy solutions.

Our cyber-security and privacy solutions for consumers provide a wide security blanket against ransomware, viruses, phishing, and other online threats, as well as a powerful, secured, and encrypted connection, masking their online activity and keeping them safe from hackers. The solutions are designed for both advanced and basic users, ensuring full protection for all personal and digital information.

Our privacy solutions for enterprises are based on our advanced and secured proxy network, the world’s fastest, enabling our customers to collect data anonymously at any scale from any public sources over the web using a unique hybrid network. Our network is the only one of its kind that is comprised of millions of residential exit points based on our proprietary reflection technology and hundreds of servers located at our ISP partners around the world. The infrastructure is optimally designed to guarantee the privacy, quality, stability, and the speed of the service.

Our cyber-security solutions for enterprises, designed for cloud, on-premises, and hybrid networks, mitigates attacks on enterprises’ business-critical services and sensitive data, while ensuring uninterrupted business continuity. Organizational data access, storage, and exchange use cases, from outside the organization or within, are secured according to the “validate first, access later” philosophy of Safe-T’s zero trust. Our ZoneZero® solutions are available by our reseller, TerraZone Ltd., a global information security provider, as a solution or cloud service.

For more information about Safe-T, visit www.safetgroup.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Safe-T is using forward-looking statements in this press release when it discusses the benefits of its Consumer Privacy solution and its potential to address market need and/or demand, its intention to continue to invest in its technology to provide the best solutions to its current and future customers, and intention to increase high-margin growth in recurring revenue. Because such statements deal with future events and are based on Safe-T’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Safe-T could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Safe-T’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 29, 2022, and in any subsequent filings with the SEC. Except as otherwise required by law, Safe-T undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Safe-T is not responsible for the contents of third-party websites.

INVESTOR RELATIONS CONTACTS:

Steve Gersten, Director of Investor Relations
Safe-T Group Ltd.
813-334-9745
[email protected]

Michal Efraty
Investor Relations, Israel
+972-(0)52-3044404
[email protected]

• Randomized, controlled clinical trial data on advanced dry eye patients from the OLYMPIA trial recently published in Clinical Ophthalmology
• Study authors concluded that the TearCare procedure delivered superior symptoms improvements over LipiFlow in patients suffering from advanced dry eye disease. These patients experienced significantly better symptoms improvements, quality of vision, and symptom frequency

MENLO PARK, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives today announced Clinical Ophthalmology has published data from a subgroup analysis of the OLYMPIA trial, which showed a single treatment with the TearCare System led to superior symptoms relief across the following primary symptoms endpoints (Ocular Surface Disease Index – OSDI, Symptom Assessment in Dry Eye – SANDE, Eye Dryness – ED) compared to a LipiFlow application in patients with more severe forms of DED due to meibomian gland dysfunction (MGD).¹

“Since obstruction of the meibomian glands is the underlying cause of MGD or evaporative dry eye, thorough and comprehensive clearance of the obstruction and the restoration of gland health and meibum production is the preferred treatment. There are different technologies available to address MGD and the unique technological design and procedural differences will naturally impact clinical outcomes and success rates. OLYMPIA demonstrated that the differentiated TearCare technology delivers differentiated clinical outcomes,” said Preeya K. Gupta, M.D., Managing Director of Triangle Eye Consultants, Raleigh, N.C. and first author on the published OLYMPIA study. “We are pleased to see that not only was TearCare able to show a clinically meaningful benefit across all DED patients regardless of severity of disease, but it also demonstrated superior symptoms outcomes among those dry eye patients with advanced disease. The subgroup analysis within OLYMPIA confirms the consistently strong clinical outcomes that many clinicians and I are seeing in our dry eye patients treated with the TearCare System.”

The OLYMPIA study was a multicenter, masked, randomized controlled trial in which 235 participants received either a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for one-month post-treatment. Signs and symptoms were assessed across widely accepted endpoints, including the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), Tear Breakup Time (TBUT) and Eye Dryness (ED) questionnaires at baseline and at one month. At one month, both treatments demonstrated a statistically significant improvement in all primary and secondary endpoints.²

In the subset of more severe patients (MGSS <7) with similar OSDI baseline, those receiving TearCare treatment (n=56) achieved an OSDI score reduction of -31.0 versus -21.4 for those that received LipiFlow treatment (n=65), a statistically significant difference in OSDI symptoms improvements in favor of TearCare. The mean reduction from baseline in SANDE frequency scores also favored a TearCare reduction of 51.9 versus LipiFlow’ s 41.5, another statistically significant difference in favor of TearCare. In evaluation of the Eye Dryness Scores within this more severe subgroup, the authors reported the treatment effect of TearCare also trended in favor of TearCare with a mean ED score difference of 8.9 (p=0.071) when compared to LipiFlow.

“As payors evaluate appropriate coverage and reimbursement for select MGD treatments, like TearCare, that are being rigorously clinically evaluated through thoughtfully designed RCTs like OLYMPIA (TearCare/device vs LipiFlow/device) and Sahara (TearCare/device vs Restasis/drug), our patients currently paying out of pocket for heat and expression MGD treatment have high expectations for noticeable improvement,” said Marc Bloomenstein, O.D., Schwartz Laser Center. “The evidence provided in this OLYMPIA subgroup analysis reinforces my confidence in TearCare as my MGD treatment of choice across all patient populations, including the more challenging advanced dry eye patients. Hopefully these study results will encourage my colleagues to establish proficiency in meibomian gland expression following the delivery of therapeutic heat delivery to the eyelids.”

“We are encouraged by the superior clinical findings in this subgroup analysis of advanced dry eye patients from the OLYMPIA trial,” said Paul Badawi, CEO of Sight Sciences. “TearCare’s intuitive design enables clinicians to thoroughly and comprehensively address the root causes of the signs and symptoms of dry eye due to MGD and these data further confirm our confidence in the clinical and economic value that TearCare brings to patients, providers and payors. On the heels of the publication of this superior symptoms data from OLYMPIA, we also announced the completion of patient enrollment in Sahara, our second major RCT where we are comparing TearCare to the standard of care in dry eye, Restasis. We look forward to the readout of TearCare (device) vs Restasis (drug) in the summer of 2023.”

* LipiFlow is a trademark of Johnson & Johnson

References:

1. Holland EJ, Loh J, Bloomenstein M, et al. A comparison of TearCare and LipiFlow systems in reducing dry eye disease symptoms associated with meibomian gland disease. Clin Ophthalmol. 2022; 16:2861-2871. doi:10.2147/OPTH.S368319

2. Gupta PK, Holland EJ, Hovanesian J, et al. TearCare for the treatment of meibomian gland dysfunction in adult patients with dry eye disease: a masked randomized controlled trial. Cornea. 2022;41(4):417-426. doi:10.1097/ICO.0000000000002837

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI^® Surgical System is a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The Company’s TearCare^® System is 510(k) cleared for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), enabling office-based clearance of gland obstructions by an eye care professional to address the leading cause of dry eye disease. For more information, visit www.sightsciences.com.

About the TearCare® System

The TearCare System is FDA cleared and indicated for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction, when used in conjunction with manual expression of the meibomian glands.

The TearCare System is the only device designed to evacuate obstructed meibomian glands while harnessing a natural blink experience. The system is comprised of single-use, universally fitting SmartLids™ which are placed on the eyelids to deliver “intelligent therapeutic heat” safely and effectively. The portable SmartHub™ communicates directly with the SmartLids to precisely control the amount of phase transition heating and the duration of treatment. After 15 minutes of therapeutic heat, the Clearance Assistant forceps allows the ECP to control expression of the stagnant, obstructed meibum expertly and precisely by targeting individual meibomian glands while obtaining full visual confirmation of the success of this personalized treatment.

Forward-Looking Statements 
This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release or during the earnings call that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These statements are not guarantees of future performance or results. The forward-looking statements are subject to and involve risks, uncertainties and assumptions, and you should not place undue reliance on these forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following: estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing; our ability to enter into and compete in new markets; execution of our market strategies; the impact of the COVID-19 pandemic on our business, our customers’ and suppliers’ businesses and the general economy; our ability to compete effectively with existing competitors and new market entrants; our ability to scale our infrastructure; our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers; our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement; potential effects of extensive government regulation; our abilities to obtain and maintain regulatory approvals and clearances for our products that support our revenue projections, business strategies and growth; our ability to successfully execute our clinical trial roadmap; our ability to obtain and maintain sufficient reimbursement for our products; our abilities to protect and scale our intellectual property portfolio; our ability to hire and retain key personnel; our ability to obtain financing in future offerings; the volatility of the trading price of our common stock; our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”); our ability to maintain proper and effective internal controls; and the other important factors discussed under the caption “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.   

Media contact 
Holly Yarbrough
RHMM Inc.
[email protected] 

Investor contact 
Philip Taylor 
Gilmartin Group 
415.937.5406 
[email protected]  

LEXINGTON, Mass., Sept. 29, 2022 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, is providing an additional $3.7 million in funding for the multiple-year cost-share contract between BARDA and T2 Biosystems. The total potential BARDA funding if all contract options are exercised is $62.0 million, reflecting a reduction in the scope of work under contract option 3.

The additional funding will be used to advance the U.S. clinical trials for the T2Resistance® Panel and T2Biothreat® Panel and file submissions to the U.S. Food and Drug Administration (FDA) for U.S. regulatory clearance.

• T2Resistance® Panel: a direct-from-blood test panel designed to run on the T2Dx Instrument and simultaneously detect thirteen antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens, which are known to cause antibiotic-resistant infections.
• T2Biothreat® Panel: a direct-from-blood test panel designed to run on the T2Dx Instrument and simultaneously detect six biothreat pathogens, including: Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, and Rickettsia prowazekii.

“We are pleased to advance the U.S. clinical trials for the T2Resistance Panel and T2Biothreat Panel, in collaboration with BARDA, and subsequently file submissions with FDA for U.S. regulatory clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “These new products will expand the test menu on our T2Dx Instrument and have the potential to reduce the threat of antimicrobial resistance and protect the nation from biothreat pathogens.”

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00053.

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Bacteria® Panel, T2Candida® Panel, T2Resistance® Panel, and T2SARS-CoV-2™ Panel and are powered by the Company’s proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, T2Lyme™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the full value of the BARDA contract, the development of products under that contract, and the potential benefit of those products with respect to the diagnosis and management of bloodstream infections, antimicrobial resistance, and patient outcomes, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the U.S. Securities and Exchange Commission, or SEC, on March 23, 2022, and other filings the company makes with the SEC from time to time. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

Investor Contact:

Philip Trip Taylor, Gilmartin Group
[email protected]
415-937-5406